FDA Clears Long-Term Laser Treatment for Inflammatory Acne Vulgaris

An announcement was made by Accure Acne, Inc., a company known for their acne treatment solutions, that they had received US Food and Drug Administration (FDA) Clearance K242035 for the long-term treatment of patients with mild-to-severe inflammatory acne vulgaris.¹

Acne, 1 of the most common inflammatory skin diseases, can be effectively addressed in almost all individuals with the condition. Severity of the condition as well as disease morphology and patient characteristics such as skin color, age, psychological burden, and motivation for disease treatment are necessary considerations prior treatment selection.²

The company's ‘Accure Laser System’ is a treatment which implements the unique 1726 nm laser wavelength. It features proprietary technology which is designed to precisely control thermal gradient depth for the purposes of targeting the sebaceous gland.

"This accomplishment is a testament to the relentless pursuit of this goal by Accure, Quanta System, and the team of clinicians and researchers who have spent many years together to bring the Accure Laser to the world", Emil Tanghetti, MD, founder of The Center for Dermatology and Laser Surgery and the first Accure Laser investigator, said in a statement. "Our journey in understanding the unique nature of this wavelength and the clinical requirements needed to deliver significant clinical outcomes was certainly challenging.”¹

Tanghetti noted that the use of temperature as an endpoint is a technical innovation which, combined with forced air cooling and real-time monitoring algorithms, provided a new option that stands alone from more traditional power-based methods.

During multiple clinical trials in the US approved by Institutional Review Boards (IRB), the laser’s "treat-to-temperature" approach was thoroughly validated. The studies indicated an average reduction of 70% in users’ counts of inflammatory lesions 6 months following 4 treatments each a month apart. The results were also noted as consistent across several different skin types and severity levels.

Early in 2024, there was a limited commercial release in the US which was completed by Accure Acne for a laser system. They demonstrated strong clinical outcomes as well as high satisfaction levels among providers and patients. Specifically, satisfaction scores averaged over 4.4 out of 5.

Following this period, the company expanded the availability of the Accure Laser System to regions such as Europe, the Caribbean, the Middle East, and the Asia Pacific. In their announcement, Accure noted that patients regardless of skin type or level of acne severity can now benefit from their laser system’s effective, safe, and long-lasting results.

"This achievement cannot be overstated," Christopher Carlton, Accure Acne's co-founder, chairman of the board, and chief executive officer, said in a statement. "After many years of rigorous technical, scientific, and clinical development, The Accure Laser has delivered yet another milestone achievement-the ability to provide a significant, sustained, and durable drug-free alternative for acne patients and their providers.”

References

1. ^{Accure Acne Announces New FDA Clearance for the Long-Term Treatment of Acne. Accure Acne, Inc. October 15, 2024. https://www.prnewswire.com/apac/news-releases/accure-acne-announces-new-fda-clearance-for-the-long-term-treatment-of-acne-302276293.html. Date accessed: October 15, 2024.}
2. ^{Eichenfield DZ, Sprague J, Eichenfield LF. Management of Acne Vulgaris: A Review. JAMA. 2021;326(20):2055–2067. doi:10.1001/jama.2021.17633.}